Myelodysplastic SyndromePhase 1/2HATCHNCT04691141
A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)
A Phase 1/2 study testing ATG-016 in people with Myelodysplastic Syndrome, run by Shanghai Antengene Corporation Limited at 6 sites in China.
Trial summary
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- ATG-016
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesChina
- Study dates
- 23 Feb 2021to 19 Sep 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- ≥18 years of age, males or females.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- A life expectancy longer than 3 months in the opinion of the investigator at the screening.
- Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.
Who cannot join
- History of central nervous system (CNS) involvement.
- Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
- History of human immunodeficiency virus (HIV) infection.
- History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
- History of allogeneic stem-cell transplantation.
- Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
- Pregnant or lactating women.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Guangdong Provincal People's Hospital
Guangzhou, Guangdong, 510000
The First Affiliated Hospital, Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310009
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266071
Shanghai the sixth people's hospital
Shanghai, Shanghai Municipality, 201306
Tianjin blood research institute
Tianjin, Tianjin Municipality, 300020
Henan Cancer Hospital
Zhengzhou, Henan, 450008
About this study
Official title: A Phase I/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) Patients After Failure of Hypomethylating Agent (HMA)-Based Therapy
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy.
Read the detailed description
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- ATG-016
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-016Drug
59 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle
| Study group | Role | What they receive |
|---|---|---|
| ATG-016 | Experimental | 5 mg QD×Days 1-5/week will be the initial dose of this study. Receives: Drug: ATG-016 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD in Phase I
MTD will be evaluated using the NCI-CTCAE, Version 5.0
Measured: 16 months
RP2D in Phase I
RP2D will be determined under the guidance of the SRC.
Measured: 16 months
AEs/SAEs
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
Measured: 25 months
ORR in Phase II
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
Measured: 25 months
Secondary outcomes (4)
Disease Control Rate (DCR) in Phase I/II
DCR (CR + PR + mCR + HI + SD)
Measured: 12 months
Duration of Response (DOR) in Phase I/II
To evaluate duration of response
Measured: 12 months
Progression-Free Survival (PFS) in Phase I/II
To evaluate progression-free survival
Measured: 12 months
Overall Survival (OS)
The estimates of Kaplan-Meier
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start23 Feb 2021
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Why it stopped: The study was stopped early because the sponsor decided to change the study-drug development strategy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Antengene Corporation Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhijian Xiao, MD, Principal investigator, Tianjin blood research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691141
- Sponsor's protocol ID
- ATG-016-MDS-001
- Acronym
- HATCH
- Status last verified
- Mar 2024
- First submitted
- 23 Dec 2020
- Last updated
- 17 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS) Patients After Failure of Hypomethylating Agent (HMA)-Based Therapy
- ClinicalTrials.gov ID
- NCT04691141
- Acronym / sponsor ID
- HATCH / ATG-016-MDS-001
- Conditions
- Myelodysplastic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped early because the sponsor decided to change the study-drug development strategy
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Shanghai Antengene Corporation LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy.
Detailed description
This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-016 | Experimental | Drug: ATG-0165 mg QD×Days 1-5/week will be the initial dose of this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
- ≥18 years of age, males or females.
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
- A life expectancy longer than 3 months in the opinion of the investigator at the screening.
- Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.
Key exclusion criteria (7 listed)
- History of central nervous system (CNS) involvement.
- Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
- History of human immunodeficiency virus (HIV) infection.
- History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
- History of allogeneic stem-cell transplantation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-01659 patients enrolled will be treated with ATG-016, orally, each 4 week (28-day) a cycle | Drug | ATG-016 |
Primary outcome
MTD in Phase I
Time frame: 16 months
MTD will be evaluated using the NCI-CTCAE, Version 5.0
RP2D in Phase I
Time frame: 16 months
RP2D will be determined under the guidance of the SRC.
AEs/SAEs
Time frame: 25 months
Toxicity will be graded according to the NCI CTCAE, Version 5.0.
ORR in Phase II
Time frame: 25 months
Based on 2006 IWG Response Criteria, evaluated by IRC: ORR (CR + PR + mCR)
4 secondary outcomes
Disease Control Rate (DCR) in Phase I/II
Time frame: 12 months
Duration of Response (DOR) in Phase I/II
Time frame: 12 months
Progression-Free Survival (PFS) in Phase I/II
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Results and safety
The study was stopped early (reason given: The study was stopped early because the sponsor decided to change the study-drug development strategy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhijian Xiao, MD principal investigator
Tianjin blood research institute
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATG-016 in people with Myelodysplastic Syndrome, run by Shanghai Antengene Corporation Limited at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped early because the sponsor decided to change the study-drug development strategy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD in Phase I (time frame: 16 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.